The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Magellan Robotic System, Magellan Robotic Catheter 9fr.
Device ID | K132369 |
510k Number | K132369 |
Device Name: | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR |
Classification | System, Catheter Control, Steerable |
Applicant | HANSEN MEDICAL, INC. 800 EAST MIDDLEFIELD ROAD Mountain View, CA 94043 |
Contact | Hassan Labay |
Correspondent | Hassan Labay HANSEN MEDICAL, INC. 800 EAST MIDDLEFIELD ROAD Mountain View, CA 94043 |
Product Code | DXX |
CFR Regulation Number | 870.1290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-30 |
Decision Date | 2013-09-27 |
Summary: | summary |